BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

【Objective】 To establish a model for predicting the risk of urinary incontinence after holmium laser enucleation of the prostate (HoLEP). 【Methods】 The clinical data of 258 patients with benign prostatic hyperplasia (BPH) who underwent HoLEP in our hospital during Jan.2019 and Feb.2022 were retrospectively analyzed. According to the occurrence of urinary incontinence after surgery, they were divided into the urinary incontinence group (n=84) and non-urinary incontinence group (n=174). Lasso regression was used to screen the predictors of urinary incontinence after HoLEP. Logistic regression was used to establish a suitable model, and a nomogram of urinary incontinence after HoLEP was drawn. Bootstrap was used to verify and draw the calibration curve of the model, calculate the C index, and draw the clinical decision curve to further verify the accuracy and identification ability of the model. 【Results】 Predictors including International Prostate Symptom Score (IPSS), Quality of Life Score (QoL), body mass index (BMI), diabetes, prostate volume (PV), and prostate-specific antigen (PSA) were selected, based on which a prediction model was constructed. The area under the receiver operating characteristic (ROC) curve of the prediction model was 0.766 0, and the 95% confidence interval was 0.704-0.828. Bootstrap internal validation showed a C-index of 0.766 2, and the calibration model curve coincided well with the actual model curve. The clinical decision curve analysis showed that the model had high accuracy, and net benefit in the probability of urinary incontinence was within 10% to 82%. 【Conclusion】 IPSS, QoL, diabetes, prostate volume, and PSA are predictors that can affect the occurrence of urinary incontinence after HoLEP. The model has high accuracy, identification ability and net benefit.

Colorectal cancer (CRC) has a high incidence and mortality rate worldwide. Its lesions are associated to gene mutation, epigenetic changes and activation of related signaling pathways. microRNAs (miRNAs) are a class of non-coding RNAs of 20-24 nt in length that can regulate the expression of target mRNAs and control various cellular mechanisms. As a novel marker for the treatment and prognosis of colorectal cancer, miRNAs are closely related to the occurrence and progression of colorectal cancer. In this review, we summarize the miRNAs dysregulated in CRC tissues, analyze the relationship between specific miRNAs and CRC proliferation, metastasis, apoptosis, and chemotherapy, and present the clinical applications of miRNAs in CRC treatment and prognosis.

Objective: To investigate the clinical value of modified transperineal template-guided prostate biopsy (mTTPB) in the detection of prostate cancer. Methods: A total of 217 patients were enrolled in this study. All the patients were randomly divided into 2 groups. The control group (n=112) underwent transperineal template-guided prostate biopsy (TTPB) which was traditional transperineal template-guided 11-region biopsy. On the basis of the control group, the apex of prostate was divided into four areas for biopsy in the observation group (mTTPB). The positive rate of apex and the incidence of complications were analyzed. The prostatic specimens from the radical prostatectomy underwent whole mount sections examination. The prostate biopsy results were compared with the postoperative pathological results. Results: The average age of the control group and the observation group were (68.5±7.9) years and (67.3±8.5) years, PSA were (31.2±18.9) ng/ml and (29.7±19.5) ng/ml, prostate volume were (44.6±15.2) ml and (41.3±17.3) ml, respectively. In the control group, the positive rates of prostate cancer in 1-10 region were 24.1% (27/112), 27.7%(31/112), 23.2% (26/112), 28.6% (32/112), 26.8% (30/112), 25.0% (28/112), 26.8% (30/112), 19.6% (22/112), 25.9% (29/112), 25.0% (28/112), respectively, with an average of 25.3%. In the observation group, the positive rates in 1-10 region were 27.6% (29/105), 28.6% (30/105), 22.9% (24/105), 26.7% (28/105), 25.7% (27/105), 24.8% (26/105), 27.6% (29/105), 21.9% (23/105), 27.6% (29/105), 26.7% (28/105), respectively, with an average of 26.0%. There was no statistical difference between the two groups (P=0.904). The positive rate of apical prostate cancer in the control group and observation group was 37.5% (42/112) and 44.8% (47/105), respectively, and there was no statistical difference between the two groups (P=0.277). Patients were grouped according to PSA>20 ng/ml and PSA≤20 ng/ml. When PSA>20 ng/ml, the positive rate of apex was 58.6% (34/58) and 56.6% (30/53) respectively in the control group and the observation group, and there was no statistical difference between the two groups (P=0.830). When PSA≤20 ng/ml, the positive rate of apex was 14.8% (8/54) in the control group and 32.7% (17/52) in the observation group, with statistically significant differences (P=0.030). Before radical prostatectomy, 12 cases (57.1%) in the control group and 19 cases (73.1%) in the observation group showed apical invasion by biopsy. Results of whole mount sections examination in the control group showed that there were 19 cases (90.5%) with apical invasion, which was statistically different from that before surgery (P=0.035). The results of whole mount sections examination in the observation group showed that there were 23 cases (88.5%) with apex invasion, which had no statistical difference compared with that before surgery (P=0.291). There were no significant differences in the incidence of hematuria, fever, urinary retention and perineal discomfort between the observation group and the control group (all P>0.05). Conclusions mTTPB can significantly improve the detection rate of apical prostate cancer without increasing the incidence of complications, especially for patients with PSA≤20 ng/ml. Hence is safe and efficacious.

Objective To evaluate the erectile function following transperineal template-guided prostate saturation biopsy (TFPSB).Methods From June 2013 to October 2015,patients underwent prostate biopsy.All patients were indicated for biopsy according to the criteria of "Guidance on diagnosis and treatment of urology in China".Exclusion criteria include medical history of PCa,severe urinary tract infection,severe cardiovascular and cerebrovascular diseases or abnormal blood coagulation.All patients were divided into observation group (TT'PSB) or control group (traditional trans-perineal template-guided prostate biopsy,TTPB) according to patients' condition,pubic anatomy,PSA abnormality,rectal examination,imaging examination and pain tolerance,etc.Patients were evaluated for pre-biopsy erectile function with the international index of erectile function (IIEF-5).All pathology confirmed prostate cancer patients were excluded.Concomitant systemic diseases and medications that would interfere with erectile function were recorded.Patients who withdrew from the trial or used the drugs such 5-phosphodiesterase inhibitors for sexual activity improvement were excluded.Ninety-seven patients in observation group and 84 patients in control group underwent further evaluation with the IIEF-5 questionnaire at 1,3 and 6 months post-biopsy.Results The average age of the observation group and the control group were (64.1 ± 7.9) years and (61.8 ±8.9) years,PSA were (7.2 ± 3.7) ng/ml and (6.7 ± 3.4) ng/ml,prostate volume were (47.8 ±21.5)ml and (49.2 ±22.2) ml,and the BMI were (21.4 ±3.1) kg/m2 and (20.6 ±3.4) kg/m2,respectively.There was no significant difference between the two groups (P ＞ 0.05) in term of above patients' characteristics.The pre-biopsy IIEF-5 score of the observation group and the control group were 19.1 ±4.5 and 19.7 ±4.3,which had no significant difference (t =-0.890,P=0.375).One month after biopsy,the IIEF-5 of two groups were 17.4 ±4.8 and 18.2 ±4.5 respectively and both group had statistically significant difference when compared with pre-biopsy (both P ＜ 0.05),however,there was no statistical significance at 3 and 6 months after biopsy.Besides,no significant difference of the IIEF-5 score was detected between two groups in 1,3 and 6 months.Conclusions Although TTPSB may resulted in temporary (1 month) post-biopsy erection dysfunction,the erectile function recovered to pre-biopsy level at 3-6 months post-biopsy.TTPSB did not increase the risk of ED compared with traditional TTPB.

Objective To investigate the efficacy and safety of salvage radical prostatectomy for men with recurrent prostate cancer (PCa) after radiotherapy.Method Ten pathologically confirmed PCa patients who relapsed after radiotherapy from Jan.2008 to Dec.2013 were retrospectively reviewed.The mean age was (64.7 ±3.7) years,with range from 56 to 72 year.Local recurrence was confirmed by retransrectal biopsy.All patients had increased PSA and/or lower urinary tract symptoms.Pelvis MRI and bone scan were performed to detect lymph node involvement and bone metastasis.All patients received radical prostatectomy with standard pelvic lymphadenectomy.Seven received open surgery (open group),three patients underwent laparoscopic surgery (laparoscopic group).Postoperative complication and PSA level were compared.Results Salvage radical prostatectomies with lymph node dissection were performed in all patients without major complications.The mean operation time of open group versus laparoscopic group were (225 ± 57)min vs.(210 ± 80)min and the mean blood loss was (275 ± 49)ml vs.(260 ± 93) ml,both of which were with no significant difference (P ＞ 0.05).The average length of stay was (14 ± 4) vs.(8 ± 2) day with significant difference (P ＜ 0.05).No rectal injury was observed.Two (20％) patients were with positive margin,and three (30％) patients had postoperative complications,including one case of deep vein thrombosis,one case of incision infection and and one case of anastomotic leakage.After a mean of 20.6 months'follow-up,two patients (25％) reached biochemical recurrence.Conclusion Both open and laparoscopic salvage radical prostatectomies after radiotherapy failure were feasible.Largescaled prospective studies were needed to verify the long-term effectiveness.

Objective To explore the safty and feasibility of transrectal ultrasound guided transperineal seminal vesicle biopsy in the evaluation of clinical staging of prostate cancer.Methods Retrospectively study 57 suspected prostate cancer patients with seminal abnormality during 2010.7-2015.1,age ranged from 50 to 78 years,average 65 ±7 years,serum total prostate specific antigen (tPSA) 3.2-131.1 μg/L, average (23.7 ± 11.3) μg/L.Twenty-two cases had palpable prostate nodules through rectal examination.All the 57 patients underwent ultrasound and template guided transperineal prostate and seminal vesicle puncture biopsies.Results Forty-four cases out of 57 found prostate cancer cells in biopsies, and 32 cases had seminal vesicle invasion (positive group) while the other 12 were negative.Twenty cases had been performed prostatectomy in the positive group and their post-operative pathological examination all showed prostate cancer with seminal vesicle invasion.Eleven cases in the negative group had been performed prostatectomy ,and 2 cases showed seminal vesicle invasion.The clinical stages of all cases in the positive group were considered as T3b both pre-operatively and post-operatively.In the negative group however, 11 cases were considered as T2 stage pre-operatively,while 2 cases were increased to T3b stage post-operatively.The sensitivity of puncturing seminal vesicle was 91％ (20/22) ,specificity was 100.0％ (9/9).Positive predictive value was 100.0％ (20/20),while negative predictive value was 82％ (9/11).All the 57 cases did not present fever after puncture biopsies, while 23 cases presented hematuria (40％) ,20 cases presented hemospermia (35％) and 1 case presented urinary retention (2％).Conclusions Transrectal ultrasound-guided transperinealseminal vesicle puncture is safe and reliable, it helps to improve the accuracy of pre-operative staging.

Objective To evaluate the anestheisa efficacy of periprostatic nerve block in transrectal ultrasound (TRUS) guided biopsy of the prostate.Methods A total of 223 patients received prostate biopsy in our hospital from July 2010 to December 2013 were retrospectively studied,and were divided randomly into two groups.One hundred and sixteen cases in nerve block group accepted local anesthesia of prostate capsule and periprostatic nerve block after local perineal skin anesthetia,and 107 cases in local anesthesia group only accepted local perineal skin anesthetia and local anesthesia of prostate capsule.Patients in the 2 groups underwent prostate biopsy successfully.The visual analogue scale (VAS) and complications were recorded.Results The age,serum PSA level before biopsy,prostate volume and the number of puncture needles had no significant differences between the 2 groups (P＞0.05).The average VAS score was 2.3± 1.1,and 4.9±2.3 in the 2 groups.The VAS had significant difference between the 2 groups (P＜0.05).The incidences of hematuria,hemospermia and urinary retention were 37.1％ (43/116),3.4％ (4/116) and 1.7％ (2/116) in nerve block group,and 39.3％ (42/107),4.7％ (5/107) and 1.9％ (2/107) in local anesthesia group.The difference was not significant (P＞0.05).Conclusion Periprostatic nerve block for TRUS guided biopsy of the prostate could be safe with good analgesic effect.

Objective To evaluate the clinical safety and efficiency of applying 125I permanent-implant prostate brachytherapy (BRT) in elderly prostate cancer patient treatment.Methods From Jan.2007 to Dec.2011,23 elderly patients (age ≥75 years) with a diagnosis of localized prostate cancer were treated at our institution and then were evaluated retrospectively.The average age was 79.7 (ranged from 75-87) years.The average prostate volume was 52 (ranged from 35-78) ml.PSA level was 6.2±1.5 (ranged from 3.3 to 9.8) μg/L.Seven cases were in T1cN0M0,sixteen cases were in T2aN0M0.Five cases were with Gleason score of 4,two cases were with Gleason score of 5,sixteen cases were with Gleason score of 6.All patients received a single 125I permanent-implant brachytherapy with a total dosage of 145 Gy.Patients were stratified according to biochemical recurrence-free survival (bDFS),overall survival rate (OS) and complications.All the patients had not accepted anti-androgen therapy or external radiotherapy.Results The average followed up were 50 (ranged from 4 to 77) mon.After 3 months,the average serum PSA was 2.4±0.4(ranged from 0.9-3.8) μg/L,there was significant difference compared with that before treatment (P=0.003).After 1 years,the average serum PSA was 0.2-2.7 μg/L and 87％ (20/23) patient's PSA was less than 1 μg/L.2 cases had biochemical recurrence (bNED rate,91％).4 patients died,among them 1 patients died of prostate cancer.The overall survival rate was 83％,and the cancer-specific survival rate was 96％.Of the patients with urethral adverse effects,0-V adverse effect rates were 34.8％,43.5％,17.4％,4.3％,0 and 0.No serious complication such as rectal fistula occurred.Conclusions BRT is an effective and safe monotherapy in elderly prostate cancer patients.

Objective To assess the safety and efficiency of systematic transperineal ultrasound guided template positioning biopsy for the high-risk population of prostate cancer.Methods From January 2010 to January 2012 a total of 42 high-risk men of prostate cancer underwent systematic ultrasound guided biopsy using the transperineal template positioning technique.All patients got at least one previous biopsy,and all the patients showed negative results,including prostatic intraepithelial neoplasia,and/or atypical small cell acinar proliferation.During the follow-up,all the patients still had high prostate specific antigen (PSA) velocity (＞ 0.75 μg/L) or high PSA level (＞ 10 μg/L).Results A mean of 18.7 biopsy cores had been obtained.Cancer was identified in 19 of the 42 men (44％).The mean Gleason score was 6 (from 4 to 9).Mean prostate volume in the positive and negative biopsy groups was 44 and 71 ml.The only significant independent influence factor for positive biopsy was prostate volume (P ＜ 0.05).The positive rate showed no statistic difference in term of presence of PIN,AHH,the number of biopsy sites,or PSA value (P ＞0.05).Adenocarcinoma was found in transition zone in 14 of 19 cases (74％),and 5 (36％) was positive only in the transition zone.Complications were rare and self-limiting,including hematuria (29％)and urinary retention (0.9％).Conclusions Systematic transperineal template positioning biopsy of the prostate is a safe and precise biopsy technique in patients who remain at high-risk for prostate adenocarcinoma.